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A Double Blind, Randomized, Placebo-controlled, Phase 1/2 Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Effects on Clinical Outcomes of OT-58, Administered Subcutaneously in Patients With Cystathionine Beta-Synthase Deficient Homocystinuria (CBSDH).

Trial Profile

A Double Blind, Randomized, Placebo-controlled, Phase 1/2 Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Effects on Clinical Outcomes of OT-58, Administered Subcutaneously in Patients With Cystathionine Beta-Synthase Deficient Homocystinuria (CBSDH).

Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 21 Dec 2018

At a glance

  • Drugs OT-58 (Primary)
  • Indications Homocystinuria
  • Focus Adverse reactions
  • Sponsors Orphan Technologies
  • Most Recent Events

    • 18 Sep 2018 Planned End Date changed from 1 Sep 2019 to 1 Oct 2019.
    • 18 Sep 2018 Planned primary completion date changed from 1 Sep 2019 to 1 Oct 2019.
    • 18 Sep 2018 Status changed from not yet recruiting to recruiting.
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